The Irritection® Assay System is a standardized and quantitative in vitro test method which utilizes changes of relevant macromolecules to predict the ocular and dermal irritancy of chemicals, mixtures and product formulations.
- The Irritection® Assay System provides an accurate and reliable GHS accepted alternative to the traditional animal tests of ocular and/or dermal irritancy, and is considerably less expensive than in vivo tests.
- Irritection® results may be obtained in as little as 1 day, versus the standard of several weeks required for in vivo studies. Rapid results provide quicker feedback on formulation changes and significantly decrease product development times.
- The Irritection® assays are quantitative and highly reproducible, thus allowing comparative ranking of samples and formulations with great accuracy.
- Prior studies have demonstrated that the Irritection® Assay results are correlated as high as 90% correlated with those obtained in GHS testing and standard Draize tests.
How the Ocular Irritection® Assay System Works
The corneal irritancy of test materials is known to be related to their propensity to promote denaturation and disruption of corneal proteins. The Ocular Irritection® Assay System is an in vitro test method that mimics these biochemical phenomena. This test consists of two essential components:
- A membrane disc that permits controlled delivery of the test material to a reagent solution and;
- A proprietary reagent solution that is composed of proteins, glycoproteins, lipids and low molecular weight components that self-associate to form a complex macromolecular matrix.
Controlled mixing of the test material and the reagent solution during the assay incubation period promotes protein denaturation and disaggregation of the macromolecular matrix. The changes in protein structure that are induced by the test material may be readily quantitated by measuring the resulting changes in turbidity (OD405) of the reagent solution.
Comparison of these optical density measurements to those produced by standard chemical irritants permits calculation of an “irritancy score” that has been shown to be directly related to the potential corneal irritancy of the test material.